MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® BIVONA® ADULT FOME-CUF® TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	850190
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received indicating that the cannula to a smiths medical portex® bivona® adult fome-cuf® tracheostomy tube broke.The hose for the cuff was also reported to be torn off.It was reported that improper use or pulling on the hose was excluded as fault.De-blocking of the cannula was performed by using an injection needle and a syringe.There were no reported adverse patient effects.
Additional Manufacturer Narrative
Device evaluation: one portex bivona adult fome-cuf tracheostomy tube kit was received for evaluation.The returned device was inflated using a needle inside the airway line.The device inflated and deflated without issue.Upon visual inspection, it was noted that the airway balloon was no longer attached to the airway line and it had not been returned with the complaint sample.The airway line was inspected under magnification at the failure point.The end of the airway line appears to be torn or cut, as shown by the jagged end of the tubing.Approximately 10mm from the end of the airway, there is a nick or cut present.The dhr review was also completed and no abnormalities were found.Based on the investigation and examination, the complaint allegation was confirmed.The problem source was noted as unknown.

• Brand Name: PORTEX® BIVONA® ADULT FOME-CUF® TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8323708
• Report Number: 3012307300-2019-00486
• Device Sequence Number: 1516824
• Product Code: JOH
• UDI-Device Identifier: 15021312006803
• UDI-Public: 15021312006803
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K913859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 09/05/2022
• Device Catalogue Number: 850190
• Device Lot Number: 3484394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1